Skip to content

Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01510002
Enrollment
640
Registered
2012-01-13
Start date
1993-01-31
Completion date
2011-12-31
Last updated
2012-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papillary Thyroid Cancer

Keywords

papillary thyroid cancer, central neck dissection, survival, locoregional control, morbidity

Brief summary

The purpose of this study is to determine whether prophylactic central neck dissection is beneficial for patients with papillary thyroid cancer staged preoperatively as node negative.

Detailed description

Several respected organizations have recently recommended that total thyroidectomy plus prophylactic central neck dissection should be the standard operation for papillary thyroid cancer. However, it is still unclear if this approach has any benefit on survival or locoregional control of the disease. In addition, potential advantages of this more aggressive surgical approach should outweigh the risk of morbidity. The purpose of this retrospective cohort study is to determine whether prophylactic central neck dissection is beneficial for patients with papillary thyroid cancer staged preoperatively as node negative. In this study outcomes of total thyroidectomy versus this plus prophylactic central neck dissection for papillary thyroid cancer are compared in a 10-year follow-up. Patients operated between 1993 and 1997 (n=282) underwent total thyroidectomy alone, whereas patients operated between 1998 and 2002 (n=358) underwent total thyroidectomy plus prophylactic central neck dissection.

Interventions

PROCEDURETotal thyroidectomy

Extracapsular total thyroidectomy

PROCEDURETotal thyroidectomy + prophylactic central neck dissection

Extracapsular total thyroidectomy plus prophylactic central neck dissection

Sponsors

Jagiellonian University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* a pathological diagnosis of papillary thyroid cancer, * in a patient with negative cervical lymph nodes on pre-, or intraoperative evaluation

Exclusion criteria

* incidental diagnosis of papillary thyroid cancer following hemithyroidectomy and requiring completion thyroidectomy, * one-stage lymph nodes dissection based on therapeutic intent, * previous thyroid surgery, * incomplete follow-up information, * incomplete histopathology report, * ASA grade higher than 3 (American Society of Anesthesiology)

Design outcomes

Primary

MeasureTime frame
overall survivalup to 10 years
disease-specific survivalup to 10 years
locoregional controlup to 10 years

Secondary

MeasureTime frame
number of patients with negative serum thyroglobulin levelsup to 10 years
postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).up to 12 months

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026